NCT06831929

Brief Summary

Develop, implement, and evaluate a culturally tailored multilevel intervention to increase uptake of the HPV vaccine among eligible patients ages 10-12 of the University of California, Davis Health Community Physician (UCDH CP) primary care practices using a randomized controlled trial design.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,232

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Feb 2025Dec 2026

First Submitted

Initial submission to the registry

February 6, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

February 28, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

11 months

First QC Date

February 6, 2025

Last Update Submit

April 22, 2025

Conditions

Keywords

HPVHuman Papillomavirus

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome: Evaluation

    Number of participants who initiate and complete the HPV vaccine series

    One year

Study Arms (2)

Control Arm

NO INTERVENTION

These clinics will not receive any intervention and will continue with care as usual.

Intervention Arm

EXPERIMENTAL

These clinics will receive the multilevel intervention which will include tailored parent/patient education, appointment scheduling assistance, and primary care team trainings.

Behavioral: Intervention Arm

Interventions

Within the intervention clinics, parents of patients between the ages of 10-12 (who are eligible for the HPV vaccine) will receive a culturally tailored customized HPV vaccine message and testimonial video from a patient/survivor of an HPV associated cancer (e.g., oropharyngeal, or cervical) via the MyChart patient portal. Parents will also receive a personal call from the research coordinator to remind them that their child is due for the HPV vaccine. If the parent is interested in scheduling the HPV vaccine appointment during this call, the research coordinator will transfer the parent to UC Davis appointment call center to schedule the appointment. Also, primary care team members will receive a semi-annual learn at lunch workshop focused on strategies to introduce the HPV vaccine to parents and how to address concerns from vaccine hesitant parents. Workshop content will be tailored/adapted to include patient/parent cultural considerations.

Intervention Arm

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Clinic patients between the ages of 10-12 who are eligible for the HPV vaccine

You may not qualify if:

  • Clinic patients who already received the HPV vaccine or with any contraindication to the HPV vaccine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis Health

Sacramento, California, 95817, United States

RECRUITING

Study Officials

  • Julie HT Dang, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramneek Kahlon, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2025

First Posted

February 18, 2025

Study Start

February 28, 2025

Primary Completion

January 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations